Dentures
Conditions
Keywords
Denture Fixative
Brief summary
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
Detailed description
A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.
Interventions
DEVICEParaffin based Denture Fixative
Denture fixative applied in strips to secure dentures in place
Sponsors
University of Leeds
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking versus no fixative control will not be possible, however, clinical outcomes assessors will be masked to the two different investigational denture fixative products
Intervention model description
The denture fixative cream formulations will be tested in a 3-arm cross-over-design, where subjects will be randomised to a sequence including the two intervention (denture fixative) arms and a control (no fixative) arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participants with a completely edentulous maxillary \[UPPER\] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular \[LOWER\], which may be restored with a stable complete, partial or implant supported denture 2. For complete denture wearers, maxillary \[UPPER\] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2) 3. Male or female participants aged between 18 and 85 years at the time of signing the informed consent form 4. Participants must have been using dentures daily for at least 6 months prior to the screening visit 5. Dentures must have been made in the last 5 years; 6. Dentures must be well-made based on design and construction in the opinion of the clinician 7. No clinically significant and relevant abnormalities in medical history or upon oral examination
Exclusion criteria
1. Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential) 2. Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator) 3. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients 4. Any clinically significant or relevant oral abnormality (e.g., temporomandibular joint \[TMJ\] problems), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the study 5. Participants with maxillofacial defects covered by prosthetics 6. Self-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the Investigator 7. Participants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Denture Retention Assessment at 1hour | 1 hour after denture fixative application or no fixative control | To assess denture retention of full maxillary arch after 1 hour with and without denture fixative using the Modified (Olshan) Kapur Index. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Denture Stability at 5minutes, 30minutes and 1hour | 5mins and 30 mins after denture fixative application or no fixative control | To assess denture stability in full mandibular arch (if present) using the Modified (Olshan) Kapur Index as separate scores at 5minutes, 30 minutes and 1 hour. |
| Denture Hold Assessment | ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control | To assess denture hold (retention and stability) at ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours using the Modified (Kulak) Kelsey questionnaire compared to no fixative control |
| Gum Comfort Assessment | At the end of each participant's day during the 4-day treatment period for each arm | To assess gum comfort using the Gum Comfort questionnaire comparing denture fixative to no fixative control over periods of 4 days (change in overall mean score and individual responses) |
| Denture Retention Assessment at 5minutes and 30minutes | 5mins and 30 mins after denture fixative application or no fixative control | To assess denture retention in full maxillary arch (and mandibular arch in fully edentulous participants) using the Modified (Olshan) Kapur Index at 5 and 30 minutes. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative. |
| Oral Health Assessment | To be completed once during the participant's clinic visit on days 2,3,4,5,6,7 and 8 comparing with and without fixative | To make a clinical assessment of the oral health impact profile of participants using the Oral Health Impact Profile-Edentulous (OHIP-EDENT) questionnaires after 4 days use of each of the dental fixatives administered and no fixative control. |
| Bite Force Assessment | To be completed once during the participant's clinic visit on days 3, 5 and 7 | To measure Bite force by means of a digital gnathometer to compare the denture fixatives to no fixative control |
| Participant Satisfaction Assessment | At the end of each participant's day during the 4-day treatment period for each arm | To assess participant satisfaction of the denture fixatives using the Modified (Kulak) Kelsey questionnaire compared to no fixative control |
Countries
United Kingdom
Outcome results
None listed